# K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Aug 30, 2007 after 86 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 54 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 23 ancestors in all.
14 later devices descend from it; 5 cite it directly.
6 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862056: [Central Venous][Multi-Lumen] Catheter W/Flex Tip, Arrow Intl., Inc. (1986) Summary page 1.
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (1990) Summary page 1.
- K962577: Arrowgard Blue Quad-Lumen Central Venous Catheter, Arrow Intl., Inc. (1997) Summary page 1.
- K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (2000) Summary page 1.
- K061179: Powerhickman Long-Term Intravascular Catheter, C.R. Bard, Inc. (2006) Summary page 1.
- K892530: Catheters for Balloon Occlusion Femoral Angiograph, Arrow Intl., Inc. (1989) Summary page 1.

## Most influential descendants
- K121501: Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) (2012), 4 descendants of its own
- K190855: BD Acute Central Line (2019), 3 descendants of its own
- K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet (2013), 3 descendants of its own
- K091709: Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC (2009), 2 descendants of its own
- K160645: PreSep Oligon Oximetry Catheter (2016), 1 descendant of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2376-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Mar 11, 2026 · Class II · Z-1914-2026: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Jan 7, 2026 · Class II · Z-2123-2026: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however,
- Aug 10, 2023 · Class I · Z-0003-2024: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Aug 10, 2023 · Class I · Z-0002-2024: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Oct 27, 2022 · Class I · Z-0352-2023: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pre
- Oct 27, 2022 · Class I · Z-0351-2023: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pre
- May 25, 2022 · Class II · Z-1604-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Apr 11, 2018 · Class II · Z-1993-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1988-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1987-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1980-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1994-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1998-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1990-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1997-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2000-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1991-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1996-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1979-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1992-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1989-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1995-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1981-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1999-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1326-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Nov 27, 2017 · Class II · Z-1005-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-1004-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-0994-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-1003-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-0995-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-0997-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-0998-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 27, 2017 · Class II · Z-0999-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Nov 14, 2017 · Class II · Z-1159-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Nov 14, 2017 · Class II · Z-1162-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Nov 14, 2017 · Class II · Z-1166-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Nov 14, 2017 · Class II · Z-1164-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Nov 14, 2017 · Class II · Z-1163-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Nov 14, 2017 · Class II · Z-1161-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Nov 14, 2017 · Class II · Z-1165-2018: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during 
- Oct 17, 2017 · Class II · Z-0653-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0655-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0647-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0649-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- Oct 17, 2017 · Class II · Z-0651-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- May 9, 2017 · Class II · Z-2330-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Mar 17, 2017 · Class II · Z-1879-2017: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
- Jun 2, 2016 · Class II · Z-2136-2016: Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
- Jan 2, 2015 · Class II · Z-1082-2015: Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

## Indications for use
The ARROWg+ard Blue® antimicrobial catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: * Lack of usable peripheral IVsites * Central venous pressure monitoring * Total parenteral nutrition (TPN) * Infusions of fluids, medications, or chemotherapy * Frequent blood sampling or receiving blood transfusions/blood products * Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi. The ARROWg+ard Blue PLUS® antimicrobial multiple-lumen catheter is indicated to permit shodt-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: * Replacement of multiple peripheral sites for IV access * Lack of usable peripheral IV sites * Central venous pressure monitoring * Total parenteral nutrition (TPN) * Infusion of incompatible medications * Multiple infusions of fluids, medications, or chemotherapy * Frequent blood sampling or receiving blood transfusions/blood products * Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values * Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi. The Arrow catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including. but not limited to the following: * Replacement of multiple peripheral sites for IV access * Lack of usable peripheral IV sites * Central venous pressure monitoring * Total parenteral nutrition (TPN) * Infusion of incompatible medications * Multiple infusions of fluids, medications, or chemotherapy * Frequent blood sampling or receiving blood transfusions/blood products * Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values * Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.

Source page: https://510kreport.com/device/K071538
Methodology: https://510kreport.com/methodology